摘要
论述大容量注射剂质量风险管理的必要性,并参照目前国外药品行业较常用的两种风险管理方法HACCP和FMEA法,介绍了大容量注射剂开展风险管理的一般过程。
It illustrates the need to develop the risk management of the large volume infusion solution,and introduces general course of risk management referring to two methods of risk management Hazard Analysis and Critical Control Points（HACCP） and Failure Mode Effects Analysis（FMEA）,which are in common use by overseas pharmaceutical industry.
出处
《中国药物警戒》
2010年第8期477-481,共5页
Chinese Journal of Pharmacovigilance
关键词
大容量注射剂
风险管理
危害分析
large volume infusion solution
risk management
hazard analysis
